MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DORADO; PTA BALLOON DILATATION CATHETER

Catalog Number	DR8084
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A patient underwent a percutaneous transluminal angioplasty (pta) procedure using the dorado pta balloon catheter.Prior to the procedure, shaft was allegedly broken off.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H11: d2b (lit; dqy) h11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one dorado pta dilatation catheter in two segments.Upon visual inspection, the device was returned in two segments with the balloon detached from the proximal glue joint.Segment 1 consists of the balloon which had the protective balloon sleeve over.The proximal end of the balloon glue joint was noted to be detached from the outer catheter shaft.The protective sleeve was removed from the balloon.Segment 2 consists of the catheter shaft of the sample and bifurcate, luers and glue fillets.No anomalies to the luers, bifurcate or glue fillets.No functional testing was performed due to the nature of the complaint.One photo was provided and reviewed.The photo shows the dorado device kept in a transparent packaging and device is partially visible.The labeling details in the photo match with the information available in trackwise.The event information was mentioned hand-written above the packaging.No other anomalies were noted.Therefore, the investigation is confirmed for the reported detachment as device was returned in two segments with balloon detached from the proximal glue joint.A definitive root cause for the reported detachment could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.E1, g3, h6 (component, method, result, conclusion).Section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
A patient underwent a percutaneous transluminal angioplasty (pta) procedure using the dorado pta balloon catheter.Prior to the procedure, shaft was allegedly broken off.The procedure was completed using another device.There was no patient contact.

• Brand Name: DORADO
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens 75751
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 22291144
• Report Number: 2020394-2025-00897
• Device Sequence Number: 20912799
• Product Code: DQY
• UDI-Device Identifier: 00801741059254
• UDI-Public: (01)00801741059254(17)221127(10)93YJ0123
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DR8084
• Device Lot Number: 93YJ0123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown